Director, Clinical Operations

Posted Dec 20

JOB DESCRIPTION

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move your medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide your therapy through the most critical development milestones from the lab to planning your regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

This position oversees the Clinical Project Management department providing oversight of day-to-day responsibilities associated with the management of clinical projects. This position additionally oversees third party vendors and contractors as it pertains to clinical projects.

Essential Functions:

  • Manage and provide oversight for the clinical project management department, providing leadership and guidance to the entire project management team, including PM Management, Project Manager, Associate Project Manager and Clinical Trial Associate groups in their day-to-day activities.
  • Monitor and coordinate the efforts of the project team to ensure project milestones are met.
  • Ensure department compliance with FDA and ICH GCP regulations, Sponsor guidelines and all SOPs (internal and external) for all clinical projects.
  • Manage third parties (e.g., sites, consultants) and vendors assigned to projects including ensuring budgets are accurate and contracted services stay within contract scope.
  • Track and report key performance metrics for the department.
  • Hold routine department team meetings and produce meeting minutes as applicable.
  • Guide the project management group in reviewing clinical documents such as protocols, protocol amendments, informed consent forms, case report forms, and study plans to ensure trial parameters are being interpreted and implemented correctly.
  • Monitor trial-related reports, enrollment updates, and general trial progress.
  • Join project meetings to interact with Sponsors and ensure projects are on track. Assist with risk analysis, triage, and problem solving as trials progress.
  • Participate in the development and implementation of clinical policies and procedures, including working guidelines, SOPs, and informal processes.
  • Oversee the appropriate placement of projects within the project management team and participate in resource planning.
  • Manage electronic systems used in conjunction with clinical project management (e.g., CTMS, eTMF).
  • Recruit, interview, hire, and onboard new employees.
  • Develop a robust training plan, including written training manuals, for key department positions.
  • Ensure that the project management team is fully trained on all aspects of managing clinical oncology trials and ensure that employee training files are accurately maintained.
  • Manage employee performance by providing performance feedback, administering disciplinary action when required, and providing career development opportunities.
  • Meet routinely with direct reports and maintain timely and accurate documentation of employee performance progress.
  • Develop annual department and individual goals and objectives.
  • Prepare department operating budget and perform resource planning. Submit budget modifications as department assumptions change.
  • Review project finances and work with Business Operations and Finance to provide accurate project forecasts. Anticipate when project activities are out of scope with the contract.
  • Maintain the department in an audit-ready state. Upon notice of individual trial or department internal or external audits, prepare records and personnel for the audit. Respond to audit findings within the required timeframe.
  • Perform other responsibilities as assigned.

Job Requirements:

  • This position requires at least a Bachelor’s degree in a health science field, with Master’s degree preferred.
  • At least 10 years’ of job-related experience, including both management and clinical research experience, is required.
  • Project Management Professional (PMP) certification is a plus.
  • A good working knowledge of MS Office products including Word, Excel, PowerPoint, and Project is required.
  • Background in oncology.

Required Specialized/Technical Skills:

  • Knowledge of GCP and ICH guidelines and FDA regulations
  • Understanding of the principles of project management
  • Ability to lead and manage a project management team
  • Prior experience with managing large, multi-center studies with a deep understanding of all aspects of clinical operations including clinical trial design, study implementation, safety management, CRA/site management, and data management
  • Oncology background
  • Skilled with all Microsoft Office products, including Microsoft Project
  • Effective oral/written communication and problem-solving skills
  • Strategic thinking
  • Able to work under tight timelines

Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications.

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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